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1711-10100 General sampling, high purity application, 100 mL

1711-10100
50  
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Replacement Information
Description
Catalogue Number1711-10100
Trade Name
  • NovaSeptum®
DescriptionGeneral sampling, high purity application, 100 mL
References
Product Information
HS Code3926 90 90
Device ConfigurationSingle sampling
Fitting InletSeptum unit with a 1 mm needle
Fitting Outlet3-piece Luer
Maximum Sampling Pressure0.5 bar (7.25 psi)
Maximum Operating Temperature-20 to 50 °C
Quality LevelMQ400
Applications
ApplicationSterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤2.15 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
SterilitySterile
SterilizationBeta Irradiation (e-beam) minimum 25 kGy according to ISO 11137 TIR No. 27
Physicochemical Information
Dimensions
Needle Size1.0 mm
Volume100 mL
Materials Information
Device Material
  • Septum: Medical grade platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM 316L stainless steel
Tubing MaterialPolyethylene
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Animal Origin MaterialsPlease refer to the Animal Origin Statement
Storage and Shipping Information
Packaging Information
Bag MaterialSampling bag: polyethylene film; drainage bag: polyethylene film
Material Size50
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Katalogové číslo GTIN
1711-10100 04053252247620

Documentation

Certificates of Quality

Title
NOVASEPTUM? HIGH PURITY APPLICATION - 210701-551
NOVASEPTUM? HIGH PURITY APPLICATION - 210709-551
NOVASEPTUM? HIGH PURITY APPLICATION - 210728-557
NOVASEPTUM® HIGH PURITY APPLICATION - 210426-352
NOVASEPTUM® HIGH PURITY APPLICATION - 210505-351
NOVASEPTUM® HIGH PURITY APPLICATION - 210512-352
NOVASEPTUM® HIGH PURITY APPLICATION - 210707-351
NOVASEPTUM® HIGH PURITY APPLICATION - 210707-352
NOVASEPTUM® HIGH PURITY APPLICATION - 210820-355
NOVASEPTUM® HIGH PURITY APPLICATION - 211022-357

Data Sheet

Title
NovaSeptum®High Purity Sampling Unit

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Kategorie

Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Sampling > NovaSeptum
Small Molecule Pharmaceuticals > API Synthesis > Sterile Sampling > NovaSeptum
Biopharmaceutical Manufacturing > Formulation > Sterile Sampling > NovaSeptum
Biopharmaceutical Manufacturing > Upstream Processing > Sterile Sampling (NovaSeptum) > NovaSeptum
Biopharmaceutical Manufacturing > Harvest > Sterile Sampling > NovaSeptum
Biopharmaceutical Manufacturing > Downstream Processing > Sterile Sampling > NovaSeptum
Biopharmaceutical Manufacturing > Drug Substance > Sterile Sampling > NovaSeptum